For years, the FDA has battled against the electronic cigarette industry, pushing for new regulations and stricter supervision over manufacturing processes. Now, we face a future where the FDA will inevitably rule on how e-cigs will be regulated and the tobacco industry stands at risk of suffering big losses depending on the outcome.
The tobacco industry is currently worth more than $35 billion per year. While it is a booming industry with millions of smokers worldwide, it is also one of the most dangerous industries to public health. Cigarettes pose serious health risks, killing 50 percent of users and causing 430,000 Americans to die each year from smoking-related diseases. Many people wrongly assume the nicotine is a cigarette’s most deadly carcinogen, but this is a myth. Instead, more than 7,000 chemicals are in a tobacco cigarette and these are the cause of smoking-related death and disease.
Electronic cigarettes eliminate all of the chemicals and provide an alternative nicotine delivery system. Instead of pushing for strict regulation of e-cigs and working against the electronic cigarette industry, the FDA would do well to embrace them as a good alternative to cancer-causing tobacco cigarettes. Rather than investing so much time and money into pushing for nicotine abstinence, it would be wise to encourage safer methods of nicotine delivery.
President Obama signed the Family Smoking Prevention and Tobacco Control Act in 2009, giving the FDA authority to closely regulate tobacco products. The FDA’s Center for Tobacco Products now regulates the manufacturing, labeling, and marketing methods of all United States tobacco products. However, they do not currently have the authority to regulate electronic cigarettes.
Currently, the FDA is working towards a new “deeming rule”, which would place new regulations on nicotine-delivery devices like e-cigarettes. The results could be disastrous for e-cigarette companies and users. The FDA could eventually have authority to regulate and supervise all e-cig production, marketing, and distribution in the same way tobacco cigarettes are regulated.
The FDA has not yet released information on what kinds of regulations they intend to apply to e-cigs. However, a letter written to stakeholders does give us some clues.
“Chapter IX also subjects “new tobacco products” (i.e., products that are first marketed or modified after February 15, 2007) and “modified risk tobacco products” (i.e., products that are “sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products”) to pre-market review.”
Based on this statement, any e-cig products that was developed and sold after 2007 could potentially be banned until approved as safe by the FDA. If this would happen, the best-case scenario would be that e-cig companies could prove newer products as “substantially equivalent” to one of the products sold before 2007. However, e-cig technology has rapidly changed and new innovations have appeared constantly since 2007, making the likelihood for the FDA to accept newer e-cigs highly unlikely.
If this did occur, electronic cigarette users would no longer have access to hundreds of their favorite products. They would be forced to use only e-cigs that were available before 2007. This would inevitably cause many companies to go out of business due to the long process of FDA research and regulation.
Even without strict e-cig bans, the FDA could subject e-cig companies to extensive paperwork, manufacturing requirements, and user fees. This would lead to the demise of small e-cig companies and would only be sustainable by the largest corporations.
Ultimately, e-cig fans will just have to wait and see what develops with the FDA’s new “deeming rule”. The FDA has a tremendous opportunity to embrace nicotine-delivery products as a healthier choice than tobacco cigarettes, potentially saving thousands of lives each year.
However, they could also enact regulations against e-cigs that would make them unavailable and harder to access, leading many to turn back to tobacco cigarettes. This would lead to an unparalleled disaster for American public health. We will continue to watch this situation as it develops. Do you think the FDA should have any regulating powers over electronic cigarettes?